Regulatory Open Forum

Hello,

Can anyone confirm that the new OSHA labeling requirements apply to IVDs?  The standard states:

This section does not require labeling of the following chemicals:

1910.1200(b)(5)(iii)

Any food, food additive, color additive, drug, cosmetic, or medical or veterinary device or product, including materials intended for use as ingredients in such products (e.g. flavors and fragrances), as such terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Virus-Serum-Toxin Act of 1913 (21 U.S.C. 151 et seq.), and regulations issued under those Acts, when they are subject to the labeling requirements under those Acts by either the Food and Drug Administration or the Department of Agriculture;

It seems to me that while IVDs are under the Federal Food, Drug, and Cosmetic Act, the labeling requirements for IVDs by the FDA do not include any type of hazardous communication.  As such, OSHA requirements would apply.  This is assuming that OSHA considers an IVD manufacturer and "Chemical manufacturer."

Thank you in advance for your input!


-------------------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
-------------------------------------------

Joy,

GHS ( http://wp.me/P33LGu-4Br) is a global agreement and it is getting ready to be implemented as of June 1, 2015 in the US.  

"Chemical" means any substance, or mixture of substances.  "Any food, food additive, color additive, drug, cosmetic, or medical ....." are being treated as "chemicals."

It does apply to IVDs if it contains a hazardous chemical(s).

But we've been doing it almost the same (e.g., hazardous chemical labeling) via/through "MSDS."


Original Message:
Sent: 03-11-2015 13:02
From: Joy Pelfrey
Subject: OSHA-GHS on IVDs

Hello,

Can anyone confirm that the new OSHA labeling requirements apply to IVDs?  The standard states:

This section does not require labeling of the following chemicals:

1910.1200(b)(5)(iii)

Any food, food additive, color additive, drug, cosmetic, or medical or veterinary device or product, including materials intended for use as ingredients in such products (e.g. flavors and fragrances), as such terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Virus-Serum-Toxin Act of 1913 (21 U.S.C. 151 et seq.), and regulations issued under those Acts, when they are subject to the labeling requirements under those Acts by either the Food and Drug Administration or the Department of Agriculture;

It seems to me that while IVDs are under the Federal Food, Drug, and Cosmetic Act, the labeling requirements for IVDs by the FDA do not include any type of hazardous communication.  As such, OSHA requirements would apply.  This is assuming that OSHA considers an IVD manufacturer and "Chemical manufacturer."

Thank you in advance for your input!


-------------------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
-------------------------------------------